NCT07349329

Brief Summary

This study will evaluate the efficacy and safety of 608 in patients with nr-axSpA.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
380

participants targeted

Target at P50-P75 for phase_3

Timeline
34mo left

Started Mar 2026

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
Mar 2026Feb 2029

First Submitted

Initial submission to the registry

January 9, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 16, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

March 9, 2026

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 19, 2028

Expected
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2029

Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

2.1 years

First QC Date

January 9, 2026

Last Update Submit

January 9, 2026

Conditions

Axial Spondyloarthritis, Non-Radiographic

Outcome Measures

Primary Outcomes (1)

  • 1. The Percentage of Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 40 Response

    Assessment of Spondylo Arthritis International Society criteria (ASAS) consist of 6 domains (4 main and 2 additional assessment domains): 1. Patient's global assessment measured on a NRS; 2. Patient's assessment of back pain, measured on a NRS; 3. Function represented by Bath Ankylosing Spondylitis Functional Index (BASFI) average of 10 questions as measured by NRS; 4. Inflammation represented by mean duration and severity of morning stiffness, on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) as measured by NRS; 5. Spinal mobility represented by the Bath Ankylosing Spondylitis Metrology Index (BASMI) lateral spinal flexion assessment; 6. C-reactive protein (acute phase reactant). ASAS40 response is defined as an improvement of ≥40% and ≥2 units on a scale of 10 in at least three of the four ASAS main domains and no worsening at all in the remaining domain. A higher score on the NRS signifies higher severity.

    From Baseline to Week 16

Secondary Outcomes (1)

  • 2. The Percentage of Participants Who Achieved an Assessment of Spondylo Arthritis International Society (ASAS) 20 Response

    From Baseline to the Week 16

Study Arms (2)

608

EXPERIMENTAL

608 subcutaneous (SC) injection.

Drug: 608

Placebo

PLACEBO COMPARATOR

Placebo subcutaneous (SC) injection.

Drug: Placebo

Interventions

608DRUG

608 subcutaneous (SC) injection.

608
PlaceboDRUG

Placebo subcutaneous (SC) injection.

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female and male patients at least 18 years of age at the time of screening.
  • Diagnosis of axial spondyloarthritis according to Ankylosing Spondylo Arthritis International Society (ASAS) axial spondyloarthritis criteria
  • Objective signs of inflammation (magnetic resonance imaging (MRI) or abnormal C-reactive protein)
  • Total back pain as measured by NRS ≥ 4 at baseline

You may not qualify if:

  • Patients with other uncontrolled active inflammatory diseases.
  • Clinical laboratory tests and other tests that reveal abnormalities with clinical significance
  • Patients who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
  • History of cancer.
  • Known or suspected history of immunosuppression.
  • Known with allergic or intolerant to mometasone furoate spray or 608/placebo.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Site 01

Beijing, 100730, China

Location

MeSH Terms

Conditions

Non-Radiographic Axial Spondyloarthritis

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Study Officials

  • Qinghong Zhou, BS

    Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

    STUDY DIRECTOR

  • Xiaofeng Zeng, MD

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Qinghong Zhou, BS

CONTACT

18911301578zhouqinghong@3sbio.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2026

First Posted

January 16, 2026

Study Start

March 9, 2026

Primary Completion (Estimated)

April 19, 2028

Study Completion (Estimated)

February 21, 2029

Last Updated

January 16, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)